Keith Bratti’s Post

Did you see that new NHS England Clinical Directors and Specialty Advisers have been announced? https://lnkd.in/ecpxchiB What will this mean for your engagement strategy? What will interest the Clinical Directors for disease areas relevant to your products? What are their priorities and what does their day-to-day role look like? Whilst some remain the same and some still await appointment (notably Prescribing), many are new! With this change, Pharma and Medtech market access teams may need to update their Key Opinion Leader and influence maps. To discuss any updates and your wider strategy with our experts, email info@mtechaccess.co.uk #NHSinsights #NHSWhispers #Pharma #Medtech #KOLs #ClinicalDirectors #NHSEngland

Did you see that new NHS England Clinical Directors and Specialty Advisers have been announced? https://lnkd.in/e9bteMY4 What will this mean for your engagement strategy? What will interest the Clinical Directors for disease areas relevant to your products? What are their priorities and what does their day-to-day role look like? Whilst some remain the same and some still await appointment (notably Prescribing), many are new! With this change, Pharma and Medtech market access teams may need to update their Key Opinion Leader and influence maps. To discuss any updates and your wider strategy with our experts, email info@mtechaccess.co.uk #NHSinsights #NHSWhispers #Pharma #Medtech #KOLs #ClinicalDirectors #NHSEngland

Did you see that new NHS England Clinical Directors and Specialty Advisers have been announced? https://lnkd.in/eZ9c5Jhu What will this mean for your engagement strategy? What will interest the Clinical Directors for disease areas relevant to your products? What are their priorities and what does their day-to-day role look like? Whilst some remain the same and some still await appointment (notably Prescribing), many are new! With this change, Pharma and Medtech market access teams may need to update their Key Opinion Leader and influence maps. To discuss any updates and your wider strategy with our experts, email info@mtechaccess.co.uk #NHSinsights #NHSWhispers #Pharma #Medtech #KOLs #ClinicalDirectors #NHSEngland

We are constantly excited and passionate about making the UK an easier place to conduct clinical research. PHARMExcel ensures that it cultivates a shared passion with its sponsors and their teams by aligning our mutual goals across research we collaborate on. We are passionate about #ClinicalTrials and achieving positive outcomes for all involved, especially the patients. PHARMExcel works hard to keep its staff empowered by establishing continuous learning and development opportunities, building on their passion for success also. PHARMExcel constantly receives excellent client feedback, and recently received these kind words from one of its sponsors: “PHARMExcel’s passion for their projects, the professionalism shown by the team, combined with direct access to the CEO sets PHARMExcel apart from other CROs". Passion is just one of our core values. You can discover the other values that make PHARMExcel the right CRO to partner with here: https://loom.ly/eeweGwc What does passion mean to you? Let us know in the comments! #CRO #ClinicalTrials #Values #Passion

Our new post below provides a compelling overview of why early market access planning is so critical to an effective commercial launch. Payers and PBMs are the gatekeepers to a medicine’s market adoption, and planning for those stakeholder negotiations starts early in the development process. Companies and their Boards must adopt and apply an access mindset throughout the product lifecycle to ensure therapeutic adoption and commercial success. 

In Health Affairs Forefront, my colleagues Vrushab Gowda, MD, JD (Mass General Hospital), Ted Cho (of UCSF Health), and I lay out an innovation-driven vision for the FDA. The health policy community has long focused on centralized, administrative payment models as a solution to challenges. Instead, we must think in a dynamic fashion for a dynamic world. The FDA is a vehicle to improve competition and expand access in drug markets, through tools such as a priority review voucher for limited competition small molecule generic markets, or the creation of a behind the counter product class to permit pharmacists to dispense drugs — the latter without a need to change scope of practice or prescribing authority. With the hospital industry suffering from the ills of old operational models that are inconvenient and expensive for patients and physicians, device regulation offers an opportunity to promote innovation and consumer-centered care. Improvements to the 510(k) third party review program present an opportunity to focus the limited available FDA human capital on the review of complex devices. We can also expand consumer access to care and improving the efficiency of existing care delivery models by making possible a vast world of software medical device products through voluntary alternative pathways built around performance-driven standards. Finally, with over 30 million Americans using combustible tobacco, the FDA needs to use the tools it has available to reduce harm by finishing its PMTA review, spearhead user fees to promote pragmatic regulation of ENDS products, undertake risk communication to current tobacco users, and promulgate product standards to prevent the harms of product adulteration such as EVALI. Too long we have looked to payment policy for answers. Now is the time to think different. Read more here 👇 --------------- https://lnkd.in/gpP7bdac Eric Hargan Jacquelyn Incerto Colin Yokanovich Blake K. Thelander Barrett Tenbarge Clare Paoletta John Murphy III Zach Rothstein Mark Leahey Sheila Ann Mikhail Mark Sirgo Larry Robbins Janet Woodcock Josh Makower Gail Wilensky Kenneth Callahan III, MHA Brian M. Fahey Garrett Daniel Colin Rom Terra Marie Jouaneh Brian Yagi Shannon Sartin West Vinay Prasad Lisa Grabert Deborah Williams Daniel J. Durand Daniel Durrie Stacie Monroe Larry Bucshon, M.D. Tina Reed Harry Stein Marc Lanoue Tara Isa Koslov Neil Chilson #healthpolicy #FDA #medtech #tech #AI #medicalsoftware #automation #medicare #doctors

Market Access Mindset: Engage Early and Often In our last post (https://lnkd.in/gbJnvQdR), we spoke about the critical importance of Payer engagement. A question we often hear from clients on that topic is, “When should that process start?” The answer may surprise you. We believe that companies should engage with Payers as early as Phase II clinical development. Why? Because Payer’s want to thoroughly understand the value story and likely impacts to their respective budgets well before a medicine’s commercial launch.    With budgets under mounting pressure, Payers are becoming ever more aggressive in managing costs by limiting access to new medicines through a variety of mechanisms such as new market blocks, restricted coverage policies, step therapy and high out of pocket costs for patients. The growing prevalence of these tactics is undeniable with traditional classes of medicines. Unfortunately, it is also becoming a more common practice for “protected” areas such as oncology and rare disease. But all is not lost. There are actions manufacturers can take to minimize and overcome these risks through early and deliberate action. ·      Engage Payers when designing clinical trials to identify and utilize endpoints and data that will resonate. ·      Establish a value proposition that will justify the benefits and costs to them. ·      Create communication materials that leverage FDAMA 114 regulations and allow you to articulate the economic benefits associated with adopting your new medicine such as cost-effectiveness and budget impact models. ·      Activate key opinion leaders to advocate on your behalf and that of patients. ·      Engage pharmacy AND medical leadership when communicating the comprehensive value of therapy. ·      Determine if value-based contracts and/or warranties are appropriate and can be used to overcome objections to the price and value of your new medicine. ·      Prepare sales teams to push through access barriers (e.g., prior authorizations, step therapy, and pricing objections) and pull through formulary opportunities (e.g., parity/preferred status) Need help thinking through your Payer engagement strategy and execution timing to accelerate market adoption? Contact us at info@a3access.com.  #a3access #marketaccess #biopharma

Exciting updates from MDIC’s Commercial Payer Council! The 2nd quarterly meeting held in April offered valuable guidance for #medtech professionals on collaborating with commercial payers. Led by Harry Kotlarz of the HEPV program, industry experts shared insights on utilization management, prior authorization, health equity in #MedicareAdvantage, and the impact of new #obesity drugs on medical devices. Join the conversation and be part of shaping the future of medtech and payer collaboration! Download the Key Insights and learn more at: https://lnkd.in/ex3DGZPg #HealthcareInnovation #Medtech #HealthEconomics #MedicalDevices #commercialpayer #healthequity #medicaldevices #healthtech #reimbursement #medicare #healthtechnology

Check out our new post discussing why clinical differentiation alone is no longer sufficient for commercial success.

❗ 𝐔𝐧𝐥𝐨𝐜𝐤𝐢𝐧𝐠 #𝐌𝐚𝐫𝐤𝐞𝐭_𝐀𝐜𝐜𝐞𝐬𝐬 𝐢𝐧 𝐆𝐞𝐫𝐦𝐚𝐧𝐲: 𝐏𝐫𝐨𝐯𝐞𝐧 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 𝐟𝐨𝐫 𝐒𝐮𝐜𝐜𝐞𝐬𝐬 #Germany, a global healthcare leader, presents a vast and promising market for innovative life sciences products. However, navigating the intricate market access landscape in Germany requires a deep understanding of the unique regulatory, payer, and patient dynamics. At Bluerock Healthcare Advisors GmbH Healthcare Advisors, we specialize in helping companies successfully enter and expand their presence in the #German_market. 👉 Our seasoned team of market access experts has a proven track record of guiding clients across the medtech, biotech, and pharma sectors through the complexities of the German market. We tailor our strategies to align with each client's specific needs, considering factors such as product characteristics, target patient populations, and payer preferences. Our proven market access strategies 1️⃣ Grasp the AMNOG Regulatory Framework: The German Pharmaceuticals Market Reorganisation Act (AMNOG) introduced a value-based pricing system for pharmaceuticals, requiring companies to demonstrate the additional benefits their products offer over existing therapies. 2️⃣ Understand Payer Preferences and Negotiation Strategies: The German healthcare system is decentralized, with multiple private and public payers. We work closely with our clients to identify key decision-makers within these payer groups. 3️⃣ Cultivate Strong Relationships with Healthcare Providers: Building relationships with healthcare professionals is crucial for gaining market traction in Germany. We assist our clients in establishing strategic partnerships with key opinion leaders, hospital networks, and regional healthcare organizations. 4️⃣ Leverage Data Analytics to Inform Market Access: Germany boasts a robust healthcare data infrastructure, providing valuable insights into patient preferences, market trends, and payer behaviors. We utilize advanced analytics tools to analyze this data, enabling our clients to make informed decisions. 5️⃣ Adapt to Local Market Dynamics: Even within the German market, regional variations exist in healthcare preferences and reimbursement processes. We help! 6️⃣ Leverage Patient Advocacy Groups: Patient advocacy groups play a significant role in influencing healthcare decisions in Germany. We collaborate with our clients to engage with patient advocacy organizations, understanding their perspectives and building support for their products. 7️⃣ KOL Management through our vast database and network. With our expertise in navigating the German market access landscape, Bluerock Healthcare Advisors has helped numerous clients achieve market success. We are committed! Contact Dr. Achim Simons for a free consultation. #marketaccess #healthcare #pharmaceuticals #medtech #biotech #germany #AMNOG #valuebasedpricing #healthcareproviders #patientadvocacy #dataanalytics #bluerockhealthcareadvisors